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Purple Book reference family · 351(a) biologic

allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (tregzi)

allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq is an FDA-licensed reference biologic from Orca Biosystems Inc..

351(a) biologicBLA 125868 Orca Biosystems Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026

Reference product

Originator biologic
351(a)BLA 125868

tregzi allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq

Orca Biosystems Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq product.

    3 mo ago

allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq: frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq.

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